August 2016 decisions news release

The SMC has today published advice accepting six new medicines for routine use by NHSScotland.

Ibrutinib (Imbruvica) was accepted for the treatment of mantle cell lymphoma (MCL) after consideration under SMC’s Patient and Clinician Engagement process (PACE) for medicines that treat end of life and very rare conditions. MCL is an extremely rare, incurable, aggressive form of non-Hodgkin’s lymphoma (NHL) (a cancer of the white blood cells). In the PACE meeting, patient groups and clinicians spoke of how there are limited effective treatment options for this condition, which can make MCL extremely difficult for patients and their families to deal with. Ibrutinib is a targeted treatment for MCL, and has the advantage of being an oral capsule which is easy to administer, as well as being effective and well tolerated. It has shown high response rates and may offer a survival benefit for patients in whom there are no other effective and tolerable treatment options.

The committee also accepted a submission for ibrutinib for a sub-group of patients with chronic lymphocytic leukaemia (CLL) and rare genetic abnormalities (17p deletion or TP53 mutation). Prognosis for these patients is particularly poor. PACE participants highlighted that current treatments for this condition are limited, and that ibrutinib has been shown to delay progression of the disease and to offer patients a potential improvement in quality of life.

Nivolumab (Opdivo) is an immunotherapy that can be used to treat advanced melanoma (a form of skin cancer). The committee accepted nivolumab for use in patients who have not been previously treated with ipilimumab (another medicine used to treat melanoma). Through PACE, patient groups highlighted that melanoma affects a disproportionate number of young adults who may have significant work and family commitments. Nivolumab has been shown to delay the progression of skin cancer and also has different side-effects to some existing medicines, increasing the range of potential options for patients

Levofloxacin (Quinsair), an antibiotic, was accepted for the treatment of long-term infections caused by the bacterium Pseudomonas aeruginosa in adults who have cystic fibrosis. Cystic fibrosis is an inherited disease in which there is an accumulation of thick mucus in the lungs that allows bacteria to grow more easily, causing infections. Pseudomonas aeruginosa is a frequent cause of infections in patients with cystic fibrosis. Levofloxacin is an inhaled treatment that can be used easily, enabling patients to have a better day to day quality of life.

Alirocumab (Praluent) was accepted for the treatment of high cholesterol in patients at high cardiovascular risk in whom standard drug therapy has not lowered cholesterol levels adequately. Alirocumab will be prescribed by specialists and is administered by fortnightly injections.

Secukinumab (Cosentyx) was accepted for the treatment of psoriatic arthritis, an inflammatory joint disorder associated with psoriasis (a skin disease). Psoriatic arthritis usually develops between the ages of 30 and 50, causing stiffness, pain and lack of movement in affected joints which can be irreversible and lead to disability. This can be particularly difficult for patients to deal with as they may have work and family commitments. Current treatments may improve symptoms in the short term but they do not tackle the underlying cause of the condition. Secukinumab offers another option for those patients who have not responded to previous therapies.

Also accepted was insulin degludec (Tresiba), for the treatment of diabetes in adults. Insulin degludec is a long acting insulin administered by injection which offers another treatment option.

Following consideration through the PACE process, the committee was unable to recommend human alpha-1 proteinase inhibitor (Respreeza) for the treatment of emphysema due to severe alpha -1 proteinase inhibitor deficiency. This is an inherited disorder that can cause lung problems resulting in a progressive increase in shortness of breath. The committee did not recommend the medicine as it was not satisfied that the company’s evidence on the long term benefits of the medicine was strong enough to justify its cost to the NHS.

Professor Jonathan Fox, chairman of the SMC Committee said:

“The committee is pleased to be able to accept these six new medicines for routine use by NHSScotland, and we hope that patients will benefit from them.

"As there are currently limited treatment options for both mantle cell lymphoma and chronic lymphocytic leukaemia the advice on ibrutinib will be welcomed by patients and clinicians alike. There is also a need for additional treatments for melanoma, particularly those that can delay progression of the disease, and we hope nivolumab will be a useful treatment option."

“We know from what patients have told us that levofloxacin nebuliser solution will be a useful alternative treatment option for some cystic fibrosis patients with hard to treat infections. Alirocumab belongs to a new class of medicines that lower cholesterol and is expected to benefit patients who cannot be managed effectively with current treatments."

“It is disappointing that we were unable to accept human alpha-1 proteinase inhibitor for severe emphysema, but the committee was not satisfied that the company’s evidence on the medicine’s long term benefits would justify the cost to the NHS. We know this decision is difficult for patients and carers, but when making decisions the committee has to consider not only the patients that will be treated with that medicine, but every patient who needs treatment by NHSScotland. If SMC were to accept for routine use a medicine whose benefits are not clear, it might mean that patients with other conditions would lose out.”